PressEven Augmented Patch System for Rotator Cuff Repair Surgery

23 Dec 2020

Today I’m going to introduce you PressEven. PressEven is an augmented Patch system for rotator cuff repair surgery(also known as RCR surgery). As the name suggests, its main function is to disperse the pressure through a button like structure, and collaborate with decellularized biofilm to accelerate the growth of surrounding tissues.

There are 650 K RCR surgeries in the US every year and the number is still growing. Clinically most of these surgeries are performed under arthroscopy, we use suture anchors to stitch the torn tendon, however, to manage these sutures under arthroscopy wasn’t an easy job, it’s time consuming and accompanied by high complication rate and retear rate.

The ECM patch is rarely used in these failure cases mainly because it’s operational difficulties. It’s hard to flattened the patch under arthroscopy and sew it on the tendon.

This video demonstrates how the procedure goes. We lock one suture anchor on the humeral head and thread the sutures thru the tendon first and then thru the holes on the PressEven. Then we knot two sutures in the middle and pull the other strands of sutures to fix the augmented patch at place. And then we use a knotless anchor to fix all the sutures at the lateral side of the humerus.

The stress concentration is the leading cause of tendon cut thru, and that’s why the stitching method evolve from single row to double row to suture bridge, with wider suture and larger contact area to evenly distribute the compression force. However, nearly 40% retear rate still remain, and PressEven can optimize pressure distribution.

We can easily compare PressEven and Collagrowth with other competitors, it can not only reduce operation time, but also lower the chance of tendon rupture, both are great advantages for doctors, patients, and hospital. Furthermore, as we can see similar M&A cases happened for the past few years, the world leading companies are still looking for potential product, and that might be our great entry point.

The animal model and biocompatibility tests have been done following GLP standard, and the biomechanical property is significantly higher using PressEven. Also, the histology report shows fibrosis, neovascularization and fibrocartilage.

We are establishing quality management system following ISO 13485, and collaborate with Intai and Acro Biomedical for OEM production. We would obtain two FDA and tFDA licenses including PressEven and CollaGrowth next year, and reach out to local distributors in both Taiwan and the US at the same time. We have great connections with medical device distributors in TW and will establish our own marketing team to work with them. Together, we look forward to dominate the market in TW in 1 year with 3M revenue estimated. Meanwhile, about 4 to 20M revenue from the US market is also expected for the first year, and by that time, we believe partnership with Johnson and Johnson or Zimmer Biomet or even investment from them couldn’t be more reasonable.

Consider the regulatory pathway, PressEven would be the first priority in our developing roadmap, followed by CollaGrowth patch which would technically cooperate with Acro Biomedical. For the long-term goal, we are developing an implantable sensor called DiscoveryR which provide valuable data that help monitor postoperative rehabilitation and start a new era of precise and personalized rehab.

And of course the PressEven could also be applied on other Avulsion fractures, and this would be our second stage of business development.

Our team includes our CEO, 林佳緯, who is also an orthopedic surgeon and STB fellow. Our CTO 卓威明 is a senior hardware engineer in silicon valley, experienced in wireless communication and biomedical electronics. Sebastian is a senior BD manager in orthopedics, 鄭曉謙 is a former CDE(center for drug evaluation) reviewer, and doctor 邱志浩 is our clinical consultant.

Special thanks to BE accelerator and our advisory boards including president of SC memorial hospital李佩淵, medical device authority Dr.張有德 and Peter Fitzgerald.

We are raising 1M dollars for our seed round later this year, and this money will keep us move on for one year, and help us complete the preclinical data and obtain FDA approval.

Our mission is to provide smart solution to improve continuum of care, if you are interested in our solution please send us an email or you can always find us through BE accelerator. We will reach out to you ASAP, thank you!